MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SENSOR; STYLET FOR CATHETER, GASTRO-UROLOGY

Model Number	M0066703091
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a ureteroscopy procedure in the ureter or bladder performed on (b)(6) 2023.During the procedure, when the guide wire was pulled out from the patient, the blue covering was broken.The broken piece of the guidewire was successfully retrieved, and an x-ray was completed at the end to ensure nothing was in the patient.The procedure was successfully completed with the original sensor wire device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.Block h11: updated b5: additional information received on november 3, 2023.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a ureteroscopy procedure in the ureter or bladder performed on (b)(6) 2023.During the procedure, when the guide wire was pulled out from the patient, the blue covering was broken.The broken piece of the guidewire was successfully retrieved, and an x-ray was completed at the end to ensure nothing was in the patient.The procedure was successfully completed with the original sensor wire device.There were no patient complications reported as a result of this event.Additional information received that the broken piece of wire was successfully removed using graspers.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of sleeve detached.Block h10: the returned sensor wire was analyzed, and upon magnification it was observed that the sleeve was detached.No other problems with the device were noted.With all the available information, boston scientific concludes that the reported event of sleeve detached was confirmed.It is possible that the excess of force applied to remove the wire probably caused the detachment of the sleeve.It is most likely that as part of the device manipulation during the procedure, an excess of force was applied to the device such as during the guidewire insertion through another device or the interaction with the scope, causing the sleeve detached.Based on the information available and investigation results, a conclusion code of adverse event related to procedure was assigned to this investigation.
Event or Problem Description
It was reported to boston scientific corporation that a sensor wire was used during a ureteroscopy procedure in the ureter or bladder performed on (b)(6) 2023.During the procedure, when the guide wire was pulled out from the patient, the blue covering was broken.The broken piece of the guidewire was successfully retrieved, and an x-ray was completed at the end to ensure nothing was in the patient.The procedure was successfully completed with the original sensor wire device.There were no patient complications reported as a result of this event.Additional information received that the broken piece of wire was successfully removed using graspers.

• Brand Name: SENSOR
• Common Device Name: STYLET FOR CATHETER, GASTRO-UROLOGY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18059700
• Report Number: 3005099803-2023-05939
• Device Sequence Number: 20511697
• Product Code: EZB
• UDI-Device Identifier: 08714729257318
• UDI-Public: 08714729257318
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/03/2026
• Device Model Number: M0066703091
• Device Catalogue Number: 670-309
• Device Lot Number: 0032153155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 11/03/2023; 12/11/2023
• Initial Report FDA Received Date: 11/02/2023
• Supplement Report FDA Received Date: 11/21/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown